Bioheart Inc. Announces Positive Results of First-Ever Human Endovascular Case Using Proprietary Heart Muscle Regeneration Technology.Business Editors/Health & Medical Writers BIOWIRE2K FORT LAUDERDALE, Fla.--(BW HealthWire)--Nov. 13, 2001 Improvements in Ejection Fraction ejection fraction n. The blood present in the ventricle at the end of diastole and expelled during the contraction of the heart. Ejection fraction , Wall Thickening and NYHA NYHA New York Heart Association Functional Class Noted At Highlighted American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. Presentation Bioheart, Inc., a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. that develops and commercializes cellular products for the treatment of cardiovascular diseases, today announced positive results of the first-ever human endoventricular case using the company's proprietary heart muscle regeneration technology. The results were presented by Patrick Serruys, M.D., Ph.D., Thorax thorax, body division found in certain animals. In humans and other mammals it lies between the neck and abdomen and is also called the chest. The skeletal frame of the thorax is formed by the sternum (breastbone) and ribs in front and the dorsal vertebrae in back. Center, Rotterdam, at the 74th Scientific Sessions of the American Heart Association in Anaheim, California, and highlighted by the AHA at a special morning press conference. "I believe this is a landmark case landmark case Law & medicine A civil or, far less commonly, criminal action that has had an impact on a particular area of medicine. that opens the door on more than a decade of careful research conducted by many scientists around the world," Professor Serruys said. "We have demonstrated that it is possible to coax the human heart to regenerate damaged tissue, improve its functional capacity, and restore a better quality of life for the patient. We have much work yet to do, but the implications of this science are staggering, and it may herald a major new direction for cardiology in this century. We have to contain our enthusiasm as this recently initiated trial will take a long course before the technology is proven out." Today's results are part of a safety evaluation leading into a controlled Phase I/II trial initiated in Europe by Professor Serruys and Peter Smits, M.D., Ph.D., also of the Thorax Center. Also assisting were Dr. Warren Sherman, Mt. Sinai Hospital, New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , and Dr. Kumar Ravi of Beth Israel Hospital See:
The Procedure Damage to the heart from a heart attack starts a cascade of disease progression that claims the lives of millions of people annually. Until now, the damage was believed to be irreversible as damaged heart muscle cells cannot regenerate or repair themselves. Young skeletal muscle cells (myoblasts), however, do regenerate, and researchers have now apparently found a way to use these cells to bring life back to scar tissue scar tissue n. Dense, fibrous connective tissue that forms over a healed wound or cut. in the heart left in the wake of heart attack. The basis of the Bioheart procedure lies in the body's own natural repair processes. To initiate the heart repair procedure, a physician harvests muscle cells from the patient's thigh. The cells are cultured, grown and purified in a delicate, proprietary process over a 3-4 week period, yielding millions of only the immature cells called "myoblasts." These are essentially muscle stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young . The physician then injects the myoblasts into the damaged area of the patient's heart to regenerate the tissue, using an endoventricular catheter introduced through a small incision in the patient's groin. Results of the First Case Professor Serruys presented the following details of the first human case using this procedure. The patient is a 78 year-old white female with a history of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. and a previous myocardial infarction myocardial infarction: see under infarction. (six years ago), presenting at NYHA Class II-III. The patient had an ejection fraction of 39%. (Ejection fraction is a measure of the heart's pumping efficiency.) Approximately three weeks following harvesting of the muscle tissue, Dr. Peter Smits gave her nine separate myoblast myoblast /myo·blast/ (mi´o-blast) an embryonic cell which becomes a muscle cell or fiber.myoblas´tic my·o·blast n. A primitive muscle cell having the potential to develop into a muscle fiber. injections, introducing via catheter a total of 25 million cells into the region in her heart of myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart. myocardial pertaining to the muscular tissue of the heart (the myocardium). dysfunction. The patient was released from the hospital the next day. At both her one and three month follow-up visits, she had improved to NYHA Class I-II, with no limitation to her physical activity due to heart disease. Her three-month post-procedure ejection fraction had improved to 45%, as measured by a physician not part of the study. Additionally, a small amount of wall thickening, a desirable outcome, was noted near the area of implantation. Five months post-procedure, the patient continues to do well, indicating clinical progress as a result of treatment with MyoCell(TM), with no confounding factors. Application to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. "This is a tremendously exciting development for the cardiology community as well as for the millions of people who have sustained damage to their hearts from a heart attack," Michael Brown, M.D., Ph.D., Chief Scientific Officer and Vice President of Clinical Affairs of Bioheart, said. "We are moving to advance the science further and bring it to the United States. Yesterday, we submitted an application to the FDA for permission to conduct a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of MyoCell(TM) which we hope to commence early next year." It is appropriate to be cautious not to over interpret these early results. Further evidence of the potential efficacy of heart muscle regeneration using myoblast implants was also presented at the American Heart Association meeting. Professor Philippe Menasche of Hospital Bichat, Paris reported on the first nine cases he has conducted independently. A cardiac surgeon, Dr. Menasche implants myoblasts in damaged heart tissue surgically, in tandem with bypass surgery Bypass surgery A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis). , rather than as a singular therapy delivered endoventricularly. "Five years ago, most people were skeptical about the possibility of regenerating heart tissue," said Howard Leonhardt, Chairman and Chief Executive Officer of Bioheart. "Thanks to the persistence of Alexander Mauro, Race Kao, George Magovern, Doris Taylor, Stuart Williams, Peter Law, Charles Murry, Ray Chiu and Juan Chachques, to name a few, we might be on the brink of something truly extraordinary and life-saving." About Bioheart, Inc. Bioheart, Inc. is focused on the discovery, development and commercialization of cellular-based products for the treatment of cardiovascular diseases, including heart attack (myocardial infarction), congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. and angina pectoris. For more information about Bioheart, please visit http://www.bioheartinc.com. This release contains certain forward-looking statements, which are based on management's current expectations and are subject to uncertainties, risks and changes in circumstances, many of which involve factors or circumstances beyond Bioheart's ability to control. These factors, risks and uncertainties could cause actual results to differ materially from historical results or those expected, estimated or anticipated in the forward-looking statements. The forward-looking statements in this release include statements addressing the following subjects: Bioheart's products under development, and research studies related to technology upon which Bioheart's products are based; potential markets and applications for Bioheart's products; human testing of Bioheart's products, and beliefs that the application of Bioheart's products to human patients may be medically or commercially successful; and Bioheart's ability to achieve its financial and business objectives. The forward-looking statements included in this press release are made as of the date hereof, and Bioheart undertakes no obligation to update or revise any such statements, whether as a result of new developments, new information or otherwise. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion